What is the Dose Response of Varying Meal Content of Fat on Postprandial Glycaemia in Children With T1DM?
REQINSOIL
1 other identifier
interventional
30
1 country
1
Brief Summary
Background: Based on international evidence, current management of people with T1DM on intensive insulin therapy (IIT) use algorithms based on the meal carbohydrate content (MCC) to calculate the prandial insulin dose. Typically, these calculations do not take into account the protein or fat content of the meal. There is a lack of clinical advice for optimal management of high protein/fat meals due to a paucity of evidence regarding the impact of protein/fat on glycaemic control. Objective: To determine the mean glucose excursion from fasting (measured by continuous glucose monitoring, CGMS) at each 30 minute interval over the 8 hour postprandial period for each test condition. Protein effects will be looked at in a separate parallel study in Australia. Hypothesis: The fat content of a meal will cause a dose-response change in the postprandial glucose concentration in children with T1DM. Research Design and Methods: Randomised cross-over study involving thirty patients. Inclusion criteria: T1DM \>1 year, aged 8-18 years, with HbA1c \<8% and BMI \<91st centile, on intensive insulin therapy. Participants will be given a test meal on 6 consecutive nights in random order; 4 test meals varying in fat content, and one 20g carbohydrate test meal with zero fat given as control meal. A CGMS will be used to assess glucose responses at 5 minute intervals for 8 hours after test meal consumption. The relationship between the fat loads in the test meals and the mean change in postprandial glucose concentration will be analysed and described. Conclusions: This study will determine whether fat causes dose dependent response in glucose concentrations leading to refining the guidelines and possible adjustment of insulin doses for the fat content of a meal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedAugust 20, 2019
August 1, 2019
3.9 years
February 19, 2015
August 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycaemic excursion
The mean glucose excursion from fasting (measured by CGMS) at each 30 minute interval over the 8 hour postprandial period for each test condition
During the 8 hours post drink
Secondary Outcomes (5)
Maximal glucose excursion
During the 24h post drink
Time to maximal glucose excursion
During the 8 hours post drink
Time until the glucose level returns to baseline
During the 8 hours post drink
Percent time in target glucose range
During the 24h post drink
Number of hypoglycaemic events in the 24h post-test meal
During the 24 hours post drink
Study Arms (6)
Fat Test drink (50g)
EXPERIMENTALThis drink contains 50g sunflower oil and vehicle (almond milk, chocolate drink powder, sweetener)
Fat Test drink (38g)
EXPERIMENTALThis drink contains 38g sunflower oil and vehicle (almond milk, chocolate drink powder, sweetener)
Fat Test drink (25g)
EXPERIMENTALThis drink contains 25g sunflower oil and vehicle (almond milk, chocolate drink powder, sweetener)
Fat Test drink (13g)
EXPERIMENTALThis drink contains 13g sunflower oil and vehicle (almond milk, chocolate drink powder, sweetener)
Fat Test drink (3g)
PLACEBO COMPARATORThis drink contains no sunflower oil and vehicle (almond milk, chocolate drink powder, sweetener)
Carbohydrate Test drink
ACTIVE COMPARATORThis drink contains 20g of glucose from de-gassed lucozade energy.
Interventions
The intervention is a drink taken 4 hours after the evening meal insulin injection, or 10PM, whichever is later. All drinks are 116-120g in weight and similar volume. All drinks are served in a double blind fashion, apart from the 20g carbohydrate which is visibly different from other drinks in colour, texture and flavour.
Eligibility Criteria
You may qualify if:
- Diagnosed with T1DM for more than 1 year
- HbA1c less than 8%
- BMI less than 91st centile
- on intensive insulin therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cork University Hospitallead
- National University of Ireland, Galway, Irelandcollaborator
- John Hunter Children's Hospitalcollaborator
Study Sites (1)
Cork University Hospital
Cork, T12 DC4A, Ireland
Related Publications (1)
Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.
PMID: 19175902BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan O'Connell, MD
Cork University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Paediatric Endocrinologist
Study Record Dates
First Submitted
February 19, 2015
First Posted
February 26, 2015
Study Start
February 1, 2015
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
August 20, 2019
Record last verified: 2019-08